Animal-Assisted Therapy in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Animal-Assisted Therapy in Middle-aged and Older Patients With Schizophrenia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04476836
• Other study ID #: 202000549B0
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: July 2020
• Source: Chang Gung Memorial Hospital
• Contact: Chyi-Rong Chen, Master
• Phone: +886-7-7317123
• Email: ccr776[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Animal-assisted therapy (AAT) can be helpful to improve the psychiatric, emotional, physical,and social status in patients with physical and mental illness and the elderly.

The study aims to investigate the effects of AAT program in middle-aged and older patients with schizophrenia. The investigators will recruit 40 patients with schizophrenia in psychiatric ward randomised into AAT group and control group. AAT group will complete the 12-week program. This study contains two assessment sessions before and after intervention, including PANSS, ACIS, MoCA-T, CHI, DASS‐21, CST, TUG and 5MWT.

Description:

Animal-assisted therapy (AAT) can be helpful to improve the outcomes of psychiatric and emotional symptoms, physical activeness, social skills, well-beings in patients with physical and mental illness and the elderly.

The study aims to assess the applications and outcomes of psychiatric symptoms, social skills, cognitive function, well-beings, emotional status and physical fitness of AAT program applied to middle-aged and older patients with chronic schizophrenia.

The investigators will recruit 40 patients with chronic schizophrenia who were admitted to day care ward and rehabilitation ward, and conduct a randomized, controlled study. 40 patients will be stratified by the ward into AAT group and control group. AAT group will complete the 12-week program. This study contains two assessment sessions completed within one week before and after 12-week program. Subjects will be evaluated by the PANSS, ACIS, MoCA-T, CHI, DASS‐21, CST, TUG and 5MWT in both sessions. Statistical analysis is examined using paired t-test to see whether there is a significant difference (based on p‐value) between the scores of two assessment sessions in the AAT and control group, and using independent t-test to see whether there is a significant difference in the change scores of two assessment sessions between the 2 groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 1, 2020
• Est. primary completion date: August 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Having a diagnosis of schizophrenia according to the DSM-5.

2. Adult aged 40 years or older.

3. Having stable physical and psychological health conditions based on master clinician judgment.

4. Having the will to participate in the study after thorough comprehension of the content.

5. Not receiving treatment protocol last half a year.

Exclusion Criteria:

1. Severe cognitive impairment e.g. aphasia, being unable to follow 3 or more orders.

2. Being allergic to animals.

3. History of Asthma.

4. Coagulation disorders

5. presenting symptoms of specific phobia, anxiety disorder and obsessive-compulsive disorder in context of dog, infection and contamination.

Related Conditions & MeSH terms

• Animal-assisted Therapy
• Schizophrenia

Intervention

Other:
• Animal-Assisted Therapy
Animal-Assisted Therapy is when animals are used in goal-directed treatment sessions. These goals can be physical, mental, emotional or social.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital, Kaohsiung Medical Center	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change scores of Positive and Negative Syndrome Scale	This test is used for measuring symptom severity of patients with schizophrenia.	Baseline, immediate after treatment
Secondary	Change scores of The Assessment of Communication and Interaction Skills	This test is an observational rating scale designed to measure communication and interaction skills.	Baseline, immediate after treatment
Secondary	Change scores of The Taiwanese version of Montreal Cognitive Assessment	This test is a cognitive screening test in the detection of mild cognitive impairment and Alzheimer's disease.	Baseline, immediate after treatment
Secondary	Change scores of Chinese Happiness Inventory	This test is a subjective measure of well-being.	Baseline, immediate after treatment
Secondary	Change scores of Depression Anxiety Stress Scales-21	This test is a 21-item self report instrument for measuring depression, anxiety and tension/stress.	Baseline, immediate after treatment
Secondary	Change scores of Chair Stand Test	This test is to measure leg strength.	Baseline, immediate after treatment
Secondary	Change scores of Timed Up and Go	This test is to assess mobility, balance, walking ability, and fall risk in older adults.	Baseline, immediate after treatment
Secondary	Change scores of The 5-Meter Walk Test	This test is to assess walking speed.	Baseline, immediate after treatment